N/A
N=19
Lingual Endurance Exercise in Treating Post-Stroke Dysphagia
Dysphagia, Oral Phase · Stroke, Ischemic
Bottom Line
View on ClinicalTrials.gov: NCT05523973 ↗Enrolled (actual)
19
Serious AEs
10.5%
Results posted
May 2025
Primary outcome: Primary: Adherence — 79 percentage of adherence
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lingual Endurance Training (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
79 | — |
| PRIMARY Change From Baseline Modified Barium Swallowing Impairment Profile (MBSImP) Oral Total Score |
0.2667 | 0.66 |
| SECONDARY Participant Improving Worst Penetration Aspiration Scale (PAS) Score |
6 | 1.0 |
| SECONDARY Change From Baseline in Post-swallow Residue (Solid) |
-1.33 | 0.09 |
| SECONDARY Change From Baseline in Post-swallow Residue (Puree) |
-.67 | .722 |
| SECONDARY Change From Baseline in Post-swallow Residue (Thin Liquids) |
-1.5 | .28 |
| SECONDARY Change From Baseline in Post-swallow Residue (Mildly Thick Liquids) |
-1.01 | .15 |
| SECONDARY Change From Baseline in Post-swallow Residue (Moderately Thick Liquids) |
.25 | .8 |
| SECONDARY Change From Baseline in Swallowing Quality of Life Questionnaire (SWAL-QoL) |
8.3 | .12 |
| SECONDARY Change From Baseline Eating Assessment Tool (EAT-10) Score |
-0.0667 | .92 |
Summary
Aim 1: Determine feasibility of lingual endurance training for individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: % patient adherence (# of attempted repetitions/# prescribed repetitions) and % dose delivery (# of repetitions meeting goal/# prescribed repetitions). Aim 2: Determine preliminary efficacy of lingual endurance training on improving critical aspects of oropharyngeal swallowing (physiologic impairments, clearance of oropharyngeal residue, airway protection), functional oral intake, and patient reported swallowing quality of life in individuals with persistent dysphagia after ischemic stroke. Primary outcome measures: improvement on videofluoroscopic assessment of swallowing function using the gold standard Modified Barium Swallowing Impairment Profile (MBSImP) Overall Impression (OI) score and Functional Oral Intake Scale (FOIS) score. Secondary outcome measures: Analysis of Swallow Physiology, Events, Timing and Kinematics (ASPEKT); airway invasion - Penetration Aspiration Scale (PAS). Patient reported outcome measures: EAT-10 (Eating Assessment Tool) and the Swallowing Quality of Life Questionnaire (SWAL-QoL).
Eligibility Criteria
Inclusion Criteria
- ≥3 months since initial diagnosis ischemic, non-hemorrhagic stroke occurring in areas involving anterior or posterior circulation and affecting underlying cortical or subcortical structures (including brainstem)
- are safe to tolerate some oral intake required for assessment of swallowing function via Modified Barium Swallow Study
- able to follow 2-step commands
- English speaking. Participants will not be considered for inclusion if they meet any of the following screening exclusion criteria
Exclusion Criteria
- a history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, or a surgical procedure involving the pharynx or larynx
- a history of other neurological disease including traumatic brain injury, multiple sclerosis, Amyotrophic lateral sclerosis (ALS), Parkinson, or dementia
- Pregnant women
- Patients with a history of Temporomandibular joint dysfunction (TMJ) or Epilepsy
Data sourced from ClinicalTrials.gov (NCT05523973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.